HIV Testing Strategies in the Perinatal Setting

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00503308
First received: July 16, 2007
Last updated: June 7, 2011
Last verified: June 2011
Results First Received: September 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Health Services Research
Conditions: HIV Infections
Pregnancy Related
Intervention: Procedure: Abbreviated HIV test counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A randomized-controlled, non-inferiority trial was conducted from October 2006 through February 2008 at San Francisco General Hospital (SFGH), the public teaching hospital of the City and County of San Francisco.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 278 English- and Spanish-speaking pregnant women were randomized to receive either abbreviated or standard nurse-performed HIV test counseling at the initial prenatal visit.

Reporting Groups
  Description
Standard Consenting Intervention The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
Abbreviated Consenting Intervention The intervention arm used a 2-sentence script which lasted approximately 30 seconds.

Participant Flow:   Overall Study
    Standard Consenting Intervention     Abbreviated Consenting Intervention  
STARTED     146     135  
COMPLETED     144     134  
NOT COMPLETED     2     1  
Protocol Violation                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Standard Consenting Intervention The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
Abbreviated Consenting Intervention The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
Total Total of all reporting groups

Baseline Measures
    Standard Consenting Intervention     Abbreviated Consenting Intervention     Total  
Number of Participants  
[units: participants]
  146     135     281  
Age  
[units: participants]
     
<=18 years     8     5     13  
Between 18 and 65 years     138     130     268  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  26.99  ± 6.1     26.39  ± 5.3     26.7  ± 5.73  
Gender  
[units: participants]
     
Female     146     135     281  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     146     135     281  



  Outcome Measures

1.  Primary:   Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)   [ Time Frame: same day as HIV test counseling (cross-sectional study) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information